Evaluation of AP-002 in Patients With Solid Tumors

NCT04143789 | Unknown Phase 1 DMC FDA Drug

• 1 other identifier: ALT-002-SRE-01
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of this trial is to define an effective and safe dose of AP-002 in advanced or recurrent solid tumors for which there are no standard therapies to use in subsequent studies in advanced or recurrent breast, non-small cell lung cancer (NSCLC) or prostate cancers.

Conditions

Solid Tumor

Outcome Measures

Primary Outcomes (2)

• Safety Assessment

  Number of participants with treatment-related adverse events (safety and tolerability) as assessed by CTCAE v4.0

  Through study completion/ up to 18 months

• Dose Assessment

  Define the recommended phase 2 dose

  Up to 6 months

Secondary Outcomes (3)

• Efficacy Assessment

  Through study completion/ up to 18 months

• Efficacy Assessment

  Through study completion/ up to 18 months

• Pharmacokinetic Assessment

  Through study completion/ up to 18 months

Study Arms (1)

Tablets to be taken orally daily for 14 of 21 day cycle

EXPERIMENTAL

AP-002 (4 mg and 20 mg tablets) to be taken orally daily for 14 days

Drug: AP-002

Interventions

AP-002 DRUG

Dose escalation

Also known as: no other names

Tablets to be taken orally daily for 14 of 21 day cycle

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Phase 1: Patients with advanced or recurrent solid tumors with target (± non-target) or with only non-target disease, for which there is no standard therapy available Phase 2: Patients with advanced or recurrent breast cancer, NSCLC, or prostate cancer with target (± non-target) or with only non-target disease for which there is no standard therapy available
• Patients with bone metastases but without target disease are eligible
• Patients with bone metastases must have at least one bone lesion that has not received radiation therapy within 6 weeks prior to Cycle 1 Day 1
• Patients must discontinue bisphosphonate and/or denosumab treatment.
• Age ≥ 18 years
• Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
• O2 saturation ≥ 92% on room air per pulse oximetry
• Exhaled nitrous oxide ≤ 50 parts per billion (ppb)
• Adequate hematologic, hepatic and renal function defined as:
• Hemoglobin ≥ 9 g/dL
• Absolute neutrophil count (ANC) ≥ 1.5 × 109/L
• Platelet count ≥ 75 × 109/L
• Total bilirubin ≤ 2 × upper limit of normal (ULN). Patients with an established diagnosis of Gilberts syndrome with an unconjugated bilirubin ≤ 2 mg/dL and conjugated bilirubin within normal limits (WNL) are eligible.
• Serum electrolytes WNL
• Transaminases ≤ 3 × ULN

You may not qualify if:

• Evidence of benign primary hyperparathyroidism, hyperthyroidism, adrenal insufficiency, vitamin D intoxication, mild alkali syndrome, sarcoidosis or other granulomatous disease
• Treatment with calcitonin, mithramycin or cinacalcet within 7 days prior to the date of the screening
• Receiving dialysis for renal failure
• Patients with a known history of clinically significant active infection, including human immunodeficiency virus (HIV), hepatitis B, or hepatitis C
• Patients with active central nervous system (CNS) metastases are not eligible, but patients with treated, stable CNS metastases are allowed
• Patients with QT interval of ≥ 480 msec on ECG
• Patients with Paget's disease of bone
• Patients of childbearing potential unwilling to abstain from sexual intercourse, or employ effective barrier methods of contraception during participation in this trial
• Pregnancy or lactation. A negative pregnancy test will be required for women of childbearing potential prior to study enrollment and will be repeated throughout the study. Women of childbearing potential will be defined as women who have not had natural or pharmacologic menopause, nor surgical sterilization.
• Patients unwilling or unable to take oral medication, requiring a nasogastric or gastrostomy tube, or unwilling to adhere to the treatment regimen and fasting requirements
• Patients unwilling to comply with all study procedures or who are unavailable for the duration of the study
• Known allergies to any components of the AP-002 Drug Product

Sponsors & Collaborators

• Altum Pharmaceuticals INC: lead

Study Sites (3)

Research Institution

Chicago, Illinois, 60208, United States

NOT YET RECRUITING

Research Site

St Louis, Missouri, 63110, United States

RECRUITING

Investigational Site

Houston, Texas, 77030, United States

RECRUITING

Study Officials

• Angela Ogden, MD

  Altum Pharmaceuticals

  STUDY CHAIR

Central Study Contacts

Dawn East, BSN,RN

CONTACT

9544330329; deast@altumpharma.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Review of safety and pharmacokinetic (PK) parameters by the Clinical Trial Review Committee (CTRC) at the completion of each dose level in the Phase 1 will determine if escalation to the next dose level may occur. Anticipated Dose Levels in the Phase 1 Portion of the Study Cohort Anticipated Dose Anticipated Sample Size Level 1 8 mg QD PO × 14 days\* (1 patient) Level 2 16 mg QD PO × 14 day\* (1 patient) Level 3 32 mg QD PO × 14 days\* (1 patient) Level 4 64 mg QD PO × 14 days\* (1 patient) Level 5 84 mg QD PO × 14 days\* (3 patients) Level 6 108 mg QD PO × 14 days\* (3 patients) Level 7 140 mg QD PO × 14 days\* (3 patients) Level 8 180 mg QD PO × 14 days\* (3 patients) \* Note: 21-day schedule with 2 weeks on, one week off. The actual sample size will be guided by the CRM; sample size may be larger for dose levels that require expansion. Interim meetings may occur when relevant new data becomes available between scheduled CTRC meetings

Study Record Dates

• First Submitted: October 4, 2019
• First Posted: October 29, 2019
• Study Start: September 27, 2019
• Primary Completion: March 1, 2021
• Study Completion: April 1, 2021
• Last Updated: October 31, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)